Neuromodulation for Central Post-stroke Pain: Mechanism, Safety and Outcome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
Central post-stroke pain (CPSP) is an often pharmacorefractory type of neuropathic pain that develops in 8% of stroke patients. CPSP has been treated with three distinct types of neuromodulation (deep brain stimulation of the sensory thalamus (Vc-DBS), motor cortex repetitive transcranial magnetic stimulation (M1-rTMS), and motor cortex stimulation (MCS)), but the level of evidence for these procedures is very low. Moreover, data on the changes in pain brain circuitry in CPSP, and the effect of neuromodulation on this circuitry is very limited.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to provide voluntary written informed consent of the participant prior to any screening procedures
Male or female patients
Aged 18-70 years
Diagnosed with definite CPSP (Treede-Klit criteria) (1, 9), which is pharmacorefractory (i.e. amitriptyline 75mg/d 4w, lamotrigine 200mg/d 8w and pregabalin 600mg/d resulting in <50% VAS reduction and/or intolerable side-effects)
Disqualifiers
Aphasia
Pregnancy or intention to become pregnant in the following year
Medical inoperability
Impossibility to temporarily withhold anticoagulation or anti-platelet medication
Trial design
Design model
Parallel
Treatments tested in this trial
MCS surgery for CPSP
DeviceThe investigational devices that will be used for the MCS surgeries are the following: the Vanta with AdaptiveStim Technology Primary cell neurostimulator or the Intellis Implantable Neurostimulator with AdaptiveStim Technology from Medtronic, Inc. (MN, USA). These implantable neurostimulators are intended to generate electrical pulses and to deliver stimulation trough one or more leads as part of a neurostimulation system for pain therapy in adults.
Vc-DBS surgery for CPSP
DeviceFor the deep brain stimulation procedure, we will use Vercise stimulators from Boston Scientific together with the Cartesia Directional Leads or the Percept PC stimulator from Medtronic.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Patients with CPSP which is pharmacorefractory and have a good analgesic response to M1-rTMSExperimental treatment 1 intervention
Group B: Patients with CPSP which is pharmacorefractory with less analgesic M1-rTMS responseExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The relative difference in pain intensity (Visual Analogue Scale; VAS) immediately following 10 sessions of active vs. inactive rTMS;
The patients will receive 10 sessions (1/d) of active and 10 sessions (1/d) of sham M1-rTMS with a 8-week wash-out period in between.
Time frame
After completion of all rTMS sessions (approximately one month before surgery)2
The relative difference in pain intensity (Visual Analogue Scale; VAS) immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS.
Stimulation will be optimised for all patients up to 5 months post-surgery (Vc-DBS or MCS). After 2 weeks of wash-out, active and inactive stimulation will be offered in a double-blinded fashion for 4 weeks, with 2 weeks of wash-out in between.
Time frame
After completion of the 4 weeks of active vs. inactive MCS or Vc-DBS (approximately at 9 months after surgery)Secondary outcomes
1
The relative difference in pain symptoms* immediately following 10 sessions of active vs. inactive rTMS;
\* as measured through the Neuropathic Pain Symptom Inventory (NPSI) and Patient Global Impression of Change (PGIC)
Time frame
Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween2
The relative difference in use of analgesics* immediately following 10 sessions of active vs. inactive rTMS;
\* as measured through the Medication Quantification Scale
Time frame
Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween3
The relative difference in functionality* immediately following 10 sessions of active vs. inactive rTMS;
\* as measured through the Functional Independence Measure (FIM)
Time frame
Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween4
The relative difference in quality of life* immediately following 10 sessions of active vs. inactive rTMS;
\* as measured through the 36-Item Short-Form Health Survey (SF-36 QoLS)
Time frame
Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetweenSponsors and contacts
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Source ClinicalTrials.gov